Adverse Event Terminology
The purpose of this working group is to:
- establish IMDRF adverse event terminology including terms for medical device malfunction, evaluation result/conclusion, patient/user outcome, and part/component of a medical device
- support the implementation and the use of the terminology through the provision of guidance documents and training materials
- improve, harmonize and where necessary expand the terminology and systems being used to code information relating to medical device adverse events.
Do you want to find a code? Browse the terms now
Are you looking for guidance on adverse event terminology ? Browse here
Do you wish to submit a request to change the AET Terminology? See this page
Work Focus 2025
- Finalisation of the Guidance Document on “Consideration for the selection of IMDRF Adverse Event Terminology (AET) codes and terms”
- Development of training material to support the introduction of the Guidance Document on “Consideration for the selection of IMDRF Adverse Event Terminology codes and terms”
- Finalisation of the updated Annual Maintenance Standard Operating Procedure (SOP)
- Review of the N43 Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes and N44 Maintenance of IMDRF AE Terminologies
- Review of the IMDRF AET working group website pages.
The latest guideline documents of Adverse Event Terminology and Coding are:
Work items
IMDRF Adverse Event Terminology Maintenance
The maintenance of the final document will be managed via the dedicated 'Adverse Event Terminology Maintenance' web page.
IMDRF Adverse Event Terminology (Excel Format)
IMDRF AE terminology is provided in Excel format under IMDRF/AE WG/N43.
Since Edition 4 published on 20 April 2020, all annexes are provided in a new common format. The contents of each column are explained in a README file.
IMDRF Adverse Event Terminology Web Browser
The web browser for IMDRF AE terms ensures user-friendly searching and hence better and more adequate use of terms by reporters/regulators.
- Annex A: Medical Device Problem
- Annex B: Cause Investigation - Type of Investigation
- Annex C: Cause Investigation - Investigation Findings
- Annex D: Cause Investigation – Investigation Conclusion
- Annex E: Health Effects - Clinical Signs and Symptoms or Conditions
- Annex F: Health Effects - Health Impact
- Annex G: Medical Device Component
- Annexes Combined: Search all annexes
Trainings
Information Session on IMDRF Guidance Document - IMDRF terminologies for categorised Adverse Event Reporting (AER): terms, terminology structure and codes,
Understanding Adverse Event Reporting is an essential part of ensuring that medical devices on the market are appropriately reported upon should post-market issues and incidents arise. This training may be considered of use to regulatory authorities, manufacturers as well as healthcare institutions.